Breast Cancer
Conditions
Brief summary
In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data in the clinical practice setting is of clinical interest.
Interventions
DRUGPalbociclib
Palbociclib administration in breast cancer patients included in a compassionate use programme. Patients were treated according to the standard of care
Sponsors
Fernando Moreno Antón
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with RH+ y HER2- metastatic breast cancer having progressed to at least 4 previous standard treatment lines in the metastatic setting, and are not eligible to receive palbociclib in a clinical trial 2. Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L) 3. Platelet count ≥100,000/mm3 (100 x 109/L) 4. Haemoglobin ≥9 g/dL 5. Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min 6. Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease) 7. AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases) 8. Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)
Exclusion criteria
1. Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation 2. Previous radiotherapy in ≥25% of bone marrow 3. QTc \>480 msec, personal or family past history of short or long QT syndrome, Brugada's syndrome, or past history of QT interval prolongation, or tachycardia with Torsade de Pointes (TdP) 4. History of any of the following conditions within 6 months of treatment initiation: myocardial infarction, unstable angina, grade ≥2 arrhythmia (CTCAE version 4.0), atrial fibrillation, coronary or peripheral artery by-pass, symptomatic congestive heart failure, stroke, or pulmonary thromboembolism 5. Known hypersensitivity to palbociclib 6. Current or recent suicidal ideation or behaviour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | through study completion, up to 9 months | Number of days between the beginning of the treatment with palbociclib and the progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | through study completion, up to 9 months | Number of adverse events between the beginning of the treatment with palbociclib and the progression |
Countries
Spain
Outcome results
None listed